A clinical study to investigate anti hair fall efficacy of ayurvedic products
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Hair density assessment, Hair Anchorage assessment , Hair fall reduction, Hair thickness assessment
研究概览
简要总结
Study will be conducted to assess the efficacy of test product in imparting Hair growth benefits. After obtaining Informed consent form and qualifying the inclusion and exclusion criteria, subjects will be enrolled into the study. The subjects will undergo wash out period. Post wash out period, test products will be dispensed to subjects. Post base line assessment subjects will be instructed to use the product for 3 months. All evaluation assessments will be done at different times – 2 week, 1 month, 2 months ,3 months and 2 weeks regression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Healthy female and males volunteers between 20-45 years of age (including both ages) 2)Volunteer presenting hair density less than 125 per square centimeter at baseline.
- •Volunteers presenting hair thinning.
排除标准
- •Volunteer pregnant or planning to become pregnant.
- •Volunteers who are breastfeeding or having stopped to breastfeed in the past three months.
- •Volunteers with any other signs of significant local irritation, erythema or skin disease on scalp as well as on the visible parts of the body skin site.
- •Volunteers with self-perceived sensitive skin.
- •Volunteers having chronic illness or had major surgery in the last year.
- •Volunteers undergoing any treatment of any skin condition on body.
结局指标
主要结局
Hair density assessment, Hair Anchorage assessment , Hair fall reduction, Hair thickness assessment
时间窗: Baseline, 1 month, 2 months and 3 months and 2 weeks regression
次要结局
- Scalp barrier assessment, Overall scalp health(Baseline, 1 month, 2 months and 3 months and 2 weeks regression)
研究者
Dr Pooja Yadav
MASCOT-SPINCONTROL India Pvt. Ltd.